Hansa Biopharma reports positive efficacy and safety results from Idefirix® European post authorization study in kidney transplantation

Rhea-AI Summary

Hansa Biopharma (NASDAQ STOCKHOLM:HNSA) reported positive topline results from the European 20-HMedIdeS-19 post authorization efficacy study of Idefirix (imlifidase) in highly sensitized kidney transplant patients.

One-year graft failure-free survival was 90%, with graft survival 92%, patient survival 98%, and mean eGFR 52.4 mL/min/1.73 m². Safety was generally consistent with prior trials, fulfilling the post-authorization obligation and supporting a planned EMA submission for full marketing authorization by end of 2026.

Positive

• PAES primary endpoint met with 90% 1-year graft failure-free survival
• One-year graft survival of 92% and patient survival of 98%
• Mean 1-year eGFR of 52.4 mL/min/1.73 m² in treated patients
• Post-authorization efficacy obligation fulfilled under conditional approval
• Planned EMA submission for conversion to full marketing authorization by end of 2026
• Study conducted across 22 centers in 11 countries with >94% patient retention

Negative

• None.

Market Context

This announcement highlights clinically meaningful one-year outcomes for Idefirix, including graft f...

Analysis

This announcement highlights clinically meaningful one-year outcomes for Idefirix, including graft failure-free survival of 90%, graft survival of 92%, and patient survival of 98% in 51 highly sensitized kidney transplant patients. The data fulfill the post-authorization efficacy study requirement and support a planned EMA submission for full marketing authorization by Q4 2026. Investors may watch for full data presentations, regulatory milestones, and real-world utilization trends across 22 centers in 11 countries.

Key Figures

Graft failure-free survival: 90% Mean eGFR: 52.4 mL/min/1.73 m² Graft survival: 92% +5 more

8 metrics

Graft failure-free survival 90% One-year outcome in PAES kidney transplant study

Mean eGFR 52.4 mL/min/1.73 m² Renal function one year after transplantation

Graft survival 92% One-year graft survival in Idefirix-treated patients

Patient survival 98% One-year patient survival in Idefirix-treated cohort

Transplant centers 22 centers Centers participating across EU and UK

Countries 11 countries EU and UK participation in PAES study

Patients enrolled 51 patients Highly sensitized kidney transplant patients treated with Idefirix

Patient retention >94% Study retention rate over one year

Key Terms

graft failure-free survival, imlifidase, estimated glomerular filtration rate (eGFR), crossmatch, +4 more

8 terms

graft failure-free survival medical

"The 1-year graft failure-free survival was 90%, which is clinically meaningful"

Graft failure-free survival measures how long patients keep a transplanted organ or tissue working without it permanently failing; it counts the time until the transplant stops functioning or the patient dies. Investors track this because it’s a key yardstick of a treatment, device or drug’s real-world benefit and commercial potential—like judging a car’s value by how long it runs without a breakdown, better durability can mean stronger sales, pricing power, and lower follow-up costs.

imlifidase medical

"Imlifidase is transforming transplantation care for highly sensitized patients in Europe"

Imlifidase is a laboratory-made enzyme that slices through existing human IgG antibodies in the blood, temporarily removing them like scissors cutting ropes that are preventing a new graft from attaching. Investors watch it because this rapid, short-term antibody removal can enable organ transplants or reset immune responses where other treatments fail, creating potential demand, regulatory scrutiny, safety considerations, and revenue upside if adopted widely.

estimated glomerular filtration rate (eGFR) medical

"renal function one year after transplantation, assessed by estimated glomerular filtration rate (eGFR)"

Estimated glomerular filtration rate (eGFR) is a test that measures how well your kidneys are filtering waste from your blood. It helps doctors check kidney health and detect problems early, much like how a water filter's effectiveness can be tested by how clean the water becomes.

crossmatch medical

"to convert a positive crossmatch against a deceased donor to negative prior to transplantation"

A crossmatch is a laboratory compatibility check done before a blood transfusion to verify that a donor’s blood will not cause a harmful reaction in a recipient. Think of it like a pre-install compatibility test that prevents a dangerous mismatch; for investors, reliable crossmatching affects demand for diagnostic equipment and services, hospital safety records, regulatory compliance, and potential costs or liability tied to transfusion outcomes.

conditional marketing authorization regulatory

"As part of the conditional marketing authorization, the European Medicines Agency (EMA) requested"

A conditional marketing authorization is a limited, temporary approval from a drug regulator that lets a medicine or vaccine be sold based on earlier or smaller amounts of safety and effectiveness data than normally required, usually because the treatment addresses a serious unmet need. It matters to investors because it can allow a company to start generating revenue sooner—like a provisional driver’s license—while carrying higher regulatory and clinical risk if follow‑up studies fail or additional data are required.

post-authorization efficacy study (PAES) regulatory

"Post Authorization Efficacy Study (PAES), an open-label confirmatory study investigating"

A post-authorization efficacy study (PAES) is a follow-up study required or requested after a medical product has been approved by regulators to confirm how well it actually works in real-world use. Think of it like test-driving a car after it’s sold to see whether it performs as advertised across different drivers and conditions; results can change prescribing habits, reimbursement, labeling or market access and therefore influence future sales and investor value.

HLA-incompatible medical

"patients who have undergone HLA-incompatible kidney transplantation following desensitization"

HLA-incompatible describes a situation where a donor’s tissue or organ carries different immune “ID tags” (human leukocyte antigens) than the recipient’s, so the recipient’s immune system recognizes it as foreign and is likely to attack it. For investors, HLA incompatibility matters because it raises the risk of transplant rejection, increases demand for matching services, immunosuppressive drugs, or alternative therapies, and can affect regulatory hurdles and commercial prospects in the transplant and cell-therapy markets.

ClinicalTrials.gov regulatory

"Information about the trial is available at ClinicalTrials.gov: NCT05369975."

clinicaltrials.gov is a publicly accessible U.S. government database that lists details, timelines and status updates for medical studies testing drugs, devices or procedures. For investors it acts like a public calendar and scoreboard—showing when trials start, are delayed, or report results—so it helps gauge a company’s development progress, regulatory risk and potential value impact before official earnings or approvals are announced.

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• The 1-year graft failure-free survival was 90%, which is clinically meaningful and supports full marketing authorization submission
• Idefirix was generally well tolerated with a safety profile consistent with previous clinical trial experience
• Submission to EMA for conversion to full marketing authorization planned for Q4 2026

LUND, Sweden, May 27, 2026 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" (NASDAQ STOCKHOLM: HNSA), today announced positive topline results from the European 20-HMedIdeS-19 Post Authorization Efficacy Study (PAES), an open-label confirmatory study investigating one-year graft failure-free survival^[*] and patient survival in highly sensitized patients who have undergone HLA-incompatible kidney transplantation following desensitization treatment with Idefirix (imlifidase).

Renée Aguiar-Lucander, CEO, Hansa Biopharma said, "These positive results represent a significant milestone for Idefirix and for Hansa. The one-year graft failure-free survival observed in this highly sensitized patient population confirms the clinical benefit of Idefirix and demonstrates expected efficacy outcomes supported by a safety profile consistent with prior clinical experience. With this post-authorization requirement fulfilled, we look forward to submitting an application for conversion to full marketing authorization to the EMA by the end of 2026."

Tomas Lorant, Associate Professor, transplant surgeon at Akademiska Hospital, Uppsala University and the coordinating investigator for the trial said, "Imlifidase is transforming transplantation care for highly sensitized patients in Europe, by enabling kidney transplantation for patients who would otherwise have remained on the transplant waiting list for an extended, often indefinite period. The PAES study results confirm the key role of imlifidase in allowing us to treat those kidney transplant patients with the highest unmet need."

Imlifidase is conditionally approved in the European Union under the brand name Idefirix as a desensitization treatment for highly sensitized adult patients prior to kidney transplantation from deceased donors. As part of the conditional marketing authorization, the European Medicines Agency (EMA) requested a post-authorization efficacy study (PAES) for Idefirix.

The first patient was enrolled in May 2022. In total, 22 transplant centers across 11 countries in the EU and the UK participated in the study. A total of 51 patients were enrolled and treated with Idefirix in the study.

The primary objective of the PAES was met, with 90% of highly sensitized kidney transplant patients achieving one-year graft failure-free survival following Idefirix pre-treatment to convert a positive crossmatch against a deceased donor to negative prior to transplantation.

Secondary objectives included evaluation of renal function one year after transplantation, assessed by estimated glomerular filtration rate (eGFR), as well as patient and graft survival at one year.

In patients treated with Idefirix, at one year, mean estimated glomerular filtration rate (eGFR) was 52.4 mL/min/1.73 m², graft survival was 92%, and patient survival was 98%.

The study was well conducted with patient retention greater than 94%. Idefirix was generally well tolerated, with a safety profile consistent with previous clinical trial experience.

The obligation to complete a post-authorization efficacy study, as defined under the conditional marketing authorization, is now considered fulfilled and an application for conversion to full marketing authorization to EMA is planned to be submitted by the end of 2026.

Full results from the PAES will be submitted for presentation at an upcoming medical congress.

Information about the trial is available at ClinicalTrials.gov: NCT05369975.

Conference Call

Hansa Biopharma will host a telephone conference today, Wednesday 27 May, 2026 at 8:00 AM EDT / 14:00 PM CEST. The event will be hosted by Renée Aguiar-Lucander, CEO, and Richard Philipson, CMO. The call will be held in English.

Slides used in the presentation will be live on the webcast during the call and will also be made available online after the call under Events and presentations | Hansa Biopharma.

To participate in the telephone conference, please use the dial-in details provided below:

Participant Dial In (USA/Canada Toll Free): +1-833-821-3542
Participant International Dial In: +1-412-652-1248
*Please ask to be joined into the Hansa Biopharma call.

Join the webcast here: Webcast | Hansa Biopharma Conference Call

This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 07:12 CEST on May 27, 2026.

Contacts for more information:

Kerstin Falck, VP Global Corporate Affairs
media@hansabiopharma.com
IR@hansabiopharma.com

Notes to editors

About highly sensitized patients

Highly sensitized patients have pre-formed antibodies called donor specific antibodies (DSAs) with a broad reactivity against human leukocyte antigens (HLAs), which can cause tissue damage and potentially transplant rejection.¹ The presence of DSAs means that highly sensitized patients tend to have limited or no access to transplant, as finding a compatible donor organ can be particularly challenging.^2,3 The complexity of their immunological profile means that highly sensitized patients spend longer time than average on transplant waiting lists, with evidence showing that this longer time waiting for a suitable donor relates to an increased mortality risk.^4,5 Across the U.S. and Europe, highly sensitized patients comprise around 10-15% of the total of patients on transplant waiting lists.^6,7

About imlifidase

Imlifidase is conditionally approved in the European Union, Norway, Liechtenstein, Iceland and the UK under the tradename Idefirix^® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Idefirix^® is also approved in Australia, Israel and Switzerland.

Information about the trial is available at ClinicalTrials.gov: NCT04935177

About Idefirix^® (imlifidase)

Imlifidase is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response.⁸ It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.

Imlifidase has conditional marketing approval in Europe and is marketed under the trade name Idefirix for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients.⁸ Idefirix was reviewed as part of the European Medicines Agency's (EMA) PRIority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.⁸

The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG antibodies was studied in four phase 2 single-arm studies in EU and US as well as a randomized, controlled Phase 3 study in US.^5,7,10-11.

In the US, the Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for imlifidase in February of 2026 and assigned a Prescription Drug User Fee Act (PDUFA) action date of December 19, 2026.

Full product information can be accessed via the initial Summary of Product Characteristics found here.

About kidney failure

Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.¹² ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.¹² A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and is cost savings compared to long-term dialysis. There are approximately 170,000 kidney patients in the U.S. and Europe waiting for a new kidney.¹³

About Hansa Biopharma

Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company developing and commercializing novel immunomodulatory therapies to transform care for patients with acute or complex immune disorders. Hansa's proprietary IgG-cleaving enzyme technology platform addresses serious unmet medical needs in transplantation, gene therapy and autoimmune diseases. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients, and HNSA-5487, a next-generation IgG-cleaving molecule that will be developed for Guillain-Barré Syndrome (GBS). Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com and follow us on LinkedIn.

©2026 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, Idefirix, and Idefirix flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved.

References

1. Eurostam Report (A Europe-wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at https://cordis.europa.eu/project/id/305385/reportin
2. Redfield RR, et al. The mode of sensitization and its influence on allograft outcomes in highly sensitized kidney transplant recipients. Nephrol Dial Transplant.2016 Oct;31(10):1746-53. doi: 10.1093/ndt/gfw099.
3. Lonze BE, et al. IdeS (Imlifidase): A Novel Agent That Cleaves Human IgG and Permits Successful Kidney Transplantation Across High-strength Donor-specific Antibody. Ann Surg. 2018 Sep;268(3):488-496. doi: 10.1097/
4. Alelign T, Ahmed MM, Bobosha K, Tadesse Y, Howe R, Petros B. Kidney Transplantation: The Challenge of Human Leukocyte Antigen and Its Therapeutic Strategies. J Immunol Res. 2018 Mar 5;2018:5986740. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5859822/
5. Heidt S, et al. Highly Sensitized Patients are Well Serves by Recieving a Compatible Organ Offer Based on Acceptable Mismatches. Front Immunol. 2021;12:687254. Available at: https://pubmed.ncbi.nlm.nih.gov/34248971/
6. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2022 Annual Data Report. U.S. Department of Health and Human Services, Health Resources and Services Administration; 2024. Accessed [June 2024].
7. Jordan SC, et al. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi: 10.1097/TP.0000000000003496.
8. European Medicines Agency. Idefirix^® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf.
9. Jordan SC, et al. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med  2017;377:442-453. DOI: 10.1056/NEJMoa16125
10. Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742.
11. Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733.
12. NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure.
13. Newsletter Transplant 2022. International figures on donation and transplantation. Available at: Newsletter Transplant - latest edition I Freepub (edgm.eu) Accessed: May 2024

^[*] Permanent return to dialysis for at least 6 weeks, retransplantation, transplantectomy or death

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2026-05-26 PAES Topline PR ENG FINAL

 

 

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SOURCE Hansa Biopharma AB

FAQ

What key results did Hansa Biopharma (HNSA) report from the Idefirix European post authorization study?

Hansa Biopharma reported that Idefirix achieved 90% one-year graft failure-free survival in highly sensitized kidney transplant patients. According to Hansa Biopharma, one-year graft survival was 92%, patient survival 98%, and mean eGFR 52.4 mL/min/1.73 m², with safety consistent with earlier trials.

How do the Idefirix (HNSA) PAES results affect Hansa Biopharma’s EMA marketing authorization plans?

The PAES results fulfill the post-authorization efficacy requirement for Idefirix’s conditional approval in Europe. According to Hansa Biopharma, this allows planning an application to the EMA for conversion to full marketing authorization by the end of 2026, subject to regulatory review.

What patient population was included in the Hansa Biopharma (HNSA) Idefirix PAES kidney transplant study?

The study enrolled highly sensitized adult patients undergoing HLA-incompatible kidney transplantation after Idefirix desensitization. According to Hansa Biopharma, 51 patients were treated across 22 transplant centers in 11 EU and UK countries, reflecting real-world European transplant practice for this high-need group.

What safety profile did Hansa Biopharma (HNSA) report for Idefirix in the European PAES?

Idefirix was generally well tolerated in the PAES kidney transplant study. According to Hansa Biopharma, the safety profile was consistent with previous clinical trial experience, and the study achieved patient retention greater than 94%, supporting the robustness of the safety observations reported.

How might the Idefirix PAES results influence the role of Hansa Biopharma (HNSA) in kidney transplantation?

The PAES results support Idefirix as a desensitization option for highly sensitized kidney transplant candidates in Europe. According to Hansa Biopharma, the data confirm Idefirix’s role in enabling HLA-incompatible transplants for patients who might otherwise remain on waiting lists long term.

When did the Hansa Biopharma (HNSA) Idefirix PAES kidney transplant study start and how many sites participated?

The first patient in the Idefirix PAES was enrolled in May 2022 at European transplant centers. According to Hansa Biopharma, 22 transplant centers in 11 countries in the EU and UK took part, enrolling and treating a total of 51 highly sensitized kidney transplant patients.